Senior Manager, Pharmacovigilance
Janux Therapeutics, San Diego, CA, United States
The Senior Manager, Pharmacovigilance will be responsible for the execution and oversight of pharmacovigilance activities for Janux programs. This individual will ensure compliance with global safety regulations and support the identification, evaluation and communication of safety information across all Janux programs. This role combines strategic oversight with hands‑on execution, ensuring integration of safety into drug development. The Senior Manager will also serve as a key liaison with internal and external stakeholders.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
Manage end‑to‑end pharmacovigilance activities for oncology clinical trials, including case intake, processing, medical review and reporting of Individual Case Safety Reports (ICSRs). Lead the development and implementation of safety management plans, risk management plans (RMPs), and signal detection strategies. Manage external PV vendors and ensure timely, high‑quality execution of contracted activities. Support preparation and submission of Development Safety Update Reports (DSURs), periodic safety reports, and safety listings. Support ongoing safety surveillance, including aggregate data review, signal detection, and risk evaluation activities. Maintain Reference Safety Information (RSI) and contribute to benefit‑risk assessment across development programs. Contribute to safety sections of clinical study protocol, informed consent forms (ICFs), investigator brochures (IBs) and clinical study reports (CSRs). Support IND/CTA submissions, amendments and regulatory interactions related to safety. Develop, implement and maintain pharmacovigilance SOPs, work instructions and training materials. Support internal audits and regulatory inspections; conduct root cause analyses and implement CAPAs as needed. Ensure PV systems and databases are compliant and inspection‑ready. Provide functional leadership and subject‑matter expertise for pharmacovigilance within cross‑functional teams. Other duties as deemed necessary. EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related field required. 8+ years of pharmacovigilance experience in the biotech or pharmaceutical industry, including proven leadership roles. Strong knowledge of global PV regulations (FDA, EMA, APAC, ICH, GVP). Experience in signal management, safety data interpretation, and regulatory reporting. Oncology and autoimmune experience will be prioritized in this role. Demonstrated experience managing CROs and external vendors. MPH or pharmacoepidemiology training desirable. Demonstrated ability to operate independently while collaborating effectively in cross‑functional teams. Excellent communication, analytical, and organizational skills. Proficiency in safety databases (e.g., Argus, ARISg) and MedDRA coding. $165,000 - $185,000 a year In addition to a competitive base salary ranging from $165,000 to $185,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available. Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, internal equity, and work location. Benefits
Annual bonus program Incentive stock option plan 401k plan with flat non‑elective employer contribution Comprehensive medical insurance with 90‑100% employer‑paid premiums Dental and vision insurance HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity) Unlimited PTO Generous holiday schedule; includes summer and winter company shutdown Relocation assistance Schedule
Monday to Friday Work Authorization
United States (Required) Additional Compensation
Annual targeted bonus % Work Location
Hybrid preferred in San Diego office. Remote permitted upon approval, with ability to travel up to 25% for meetings or site visits as required. EQUAL OPPORTUNITY EMPLOYER
Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.
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Manage end‑to‑end pharmacovigilance activities for oncology clinical trials, including case intake, processing, medical review and reporting of Individual Case Safety Reports (ICSRs). Lead the development and implementation of safety management plans, risk management plans (RMPs), and signal detection strategies. Manage external PV vendors and ensure timely, high‑quality execution of contracted activities. Support preparation and submission of Development Safety Update Reports (DSURs), periodic safety reports, and safety listings. Support ongoing safety surveillance, including aggregate data review, signal detection, and risk evaluation activities. Maintain Reference Safety Information (RSI) and contribute to benefit‑risk assessment across development programs. Contribute to safety sections of clinical study protocol, informed consent forms (ICFs), investigator brochures (IBs) and clinical study reports (CSRs). Support IND/CTA submissions, amendments and regulatory interactions related to safety. Develop, implement and maintain pharmacovigilance SOPs, work instructions and training materials. Support internal audits and regulatory inspections; conduct root cause analyses and implement CAPAs as needed. Ensure PV systems and databases are compliant and inspection‑ready. Provide functional leadership and subject‑matter expertise for pharmacovigilance within cross‑functional teams. Other duties as deemed necessary. EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related field required. 8+ years of pharmacovigilance experience in the biotech or pharmaceutical industry, including proven leadership roles. Strong knowledge of global PV regulations (FDA, EMA, APAC, ICH, GVP). Experience in signal management, safety data interpretation, and regulatory reporting. Oncology and autoimmune experience will be prioritized in this role. Demonstrated experience managing CROs and external vendors. MPH or pharmacoepidemiology training desirable. Demonstrated ability to operate independently while collaborating effectively in cross‑functional teams. Excellent communication, analytical, and organizational skills. Proficiency in safety databases (e.g., Argus, ARISg) and MedDRA coding. $165,000 - $185,000 a year In addition to a competitive base salary ranging from $165,000 to $185,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available. Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, internal equity, and work location. Benefits
Annual bonus program Incentive stock option plan 401k plan with flat non‑elective employer contribution Comprehensive medical insurance with 90‑100% employer‑paid premiums Dental and vision insurance HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity) Unlimited PTO Generous holiday schedule; includes summer and winter company shutdown Relocation assistance Schedule
Monday to Friday Work Authorization
United States (Required) Additional Compensation
Annual targeted bonus % Work Location
Hybrid preferred in San Diego office. Remote permitted upon approval, with ability to travel up to 25% for meetings or site visits as required. EQUAL OPPORTUNITY EMPLOYER
Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.
#J-18808-Ljbffr